(89 days)
LIAISON® Lyme Total Antibody Plus: The LIAISON® Lyme Total Antibody Plus assay uses chemiluminescent immunoassay (CLIA) technology for the qualitative determination of IgG and IgM antibodies to Borrelia burgdorferi in human serum and plasma (K2-EDTA, Li-heparin) samples. This assay is intended for use on samples from patients with signs and symptoms that are consistent with Lyme disease. Positive or equivocal results should be supplemented by testing with a standardized Western blot procedure. Positive supplemental results provide evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. Negative results by LIAISON® Lyme Total Antibody Plus assay should not be used to exclude Lyme disease. The test has to be performed on the LIAISON® XL Analyzer.
The LIAISON® Lyme Total Antibody Plus Control Set: The LIAISON® Lyme Total Antibody Plus Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Lyme Total Antibody Plus assay. The performance characteristics of LIAISON® Lyme Total Antibody Plus Control Set have not been established for any other assays or instrument platforms different from the LIAISON® XL.
The method for qualitative determination of IgG and IgM antibodies to Borrelia burgdorferi is an indirect chemiluminescence immunoassay (CLIA). All assay steps (with the exception of magnetic particle resuspension) and incubations are performed by the Analyzer. The principal components of the test are magnetic particles (solid phase) coated with recombinant Borrelia antigens and a conjugate reagent containing two mouse monoclonal antibodies (anti- human IgG and anti-human IgM) linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, antigen-specific antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the conjuqates react with Borrelia burgdorferi IgG and IgM antibodies captured by the solid phase. Unbound material is removed with a wash cycle following incubations. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of Borrelia burgdorferi antibodies present in calibrators, samples or controls.
The provided text describes the performance data for the DiaSorin LIAISON® Lyme Total Antibody Plus assay. Here's a breakdown of the acceptance criteria and study details based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined "acceptance criteria" in a table format with pass/fail thresholds. Instead, it presents performance data that supports the claim of substantial equivalence to a predicate device. The implied acceptance criteria are that the new device's performance is comparable to or better than the predicate device across various metrics.
However, we can infer some "performance targets" from the "First Tier Percent Agreement with Predicate Device" and "Second Tier Testing" tables.
| Performance Metric | Implied Acceptance Criteria (Goal) | Reported Device Performance (LIAISON® Lyme Total Antibody Plus) |
|---|---|---|
| First Tier Agreement: | ||
| Positive % Agreement (with Predicate) | High agreement with predicate for positive/equivocal results. | 56.5% (65/115) with 95% Cl: 47.4% - 65.2% |
| Negative % Agreement (with Predicate) | Very high agreement with predicate for negative results. | 98.7% (1416/1435) with 95% Cl: 97.9% - 99.2% |
| Second Tier Testing (PPA): | ||
| Positive Percent Agreement (with WB) | High agreement with Western Blot for predicate-positive/test-positive cases | 97.9% (47/48) with 95% Cl: 89.1%-99.6% |
| CDC Lyme Reference Sera Agreement: | ||
| Stage I Acute Agreement | High agreement with CDC classification. | 76.9% (30/39) with 95% CI: 61.7% - 87.4% (Same as Predicate) |
| Stage II Convalescent Agreement | High agreement with CDC classification. | 93.5% (29/31) with 95% CI: 79.3% - 98.2% (Same as Predicate) |
| Stage III Late Agreement | Very high agreement with CDC classification. | 100.0% (20/20) with 95% CI: 83.9% - 100.0% (Same as Predicate) |
| Look-alike Diseases Agreement | High negative agreement (low false positives). | 95.6% (86/90) with 95% CI: 89.1% - 98.3% |
| Healthy Controls Agreement | Very high negative agreement (low false positives). | 98.0% (98/100) with 95% CI: 93.0% - 99.4% |
| Precision (Total %CV): | Low variability across runs, days, and operators (lower is better). |
§ 866.3830
Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).